Business Wire

COMPASS Pathways Partners with Worldwide Clinical Trials to Conduct World’s First Large-scale Clinical Trials in Psilocybin Therapy for Treatment-resistant Depression

Del

COMPASS Pathways, a healthcare company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it is partnering with Worldwide Clinical Trials to conduct a major programme of late-stage clinical trials for psilocybin therapy for treatment-resistant depression.

Depression is the leading cause of ill-health and disability worldwide, and one of the fastest growing health problems, affecting more than 300 million people around the world.

George Goldsmith, Executive Chairman and Co-Founder, COMPASS Pathways, said, “We need a new approach to tackling mental health. Current treatments for depression work for many people but there is still a significant unmet need for a large number of patients living with this very challenging condition.

“COMPASS is making rapid progress with plans to develop psilocybin therapy for patients suffering with treatment-resistant depression. Several small, exploratory academic studies have already shown the promise of psychoactive medicine. With Worldwide as our Clinical Research Organisation (CRO) partner, we will have the extensive experience and deep expertise needed to conduct the first ever large-scale randomised, controlled trials, covering 400 patients with treatment-resistant depression in eight countries.”

The trial will begin in the first quarter of 2018 and is planned to include clinical sites in Czech Republic, Finland, Germany, the Netherlands, Norway, Portugal, Spain and the UK.

“The Worldwide team is delighted to have been selected as COMPASS’ CRO partner,” said Peter Benton, President and Chief Operating Officer at Worldwide Clinical Trials. “Worldwide and COMPASS share a commitment to medical and scientific expertise, evidence-based innovation, and new ways of working, centred around the patient. We are looking forward to working together on this exciting new therapy, which could significantly improve the lives and long-term outcomes of patients suffering with treatment-resistant depression.”

The selection of a CRO and development of clinical trial sites are the latest in a series of successful milestones for COMPASS, which completed pre-clinical trials and manufacturing to Good Manufacturing Practice (GMP) standards earlier this year. COMPASS was founded two years ago. The company is backed by a group of accomplished and successful investors, including Christian Angermeyer, Galaxy Investment Partners led by Mike Novogratz and Sam Englebardt, and Peter Thiel. COMPASS is also supported by a team of highly respected expert advisers (see below).

About COMPASS Pathways

COMPASS Pathways is a healthcare company, founded in 2015 to accelerate patient access to evidence-based innovation in mental health. We are developing psilocybin therapy through late-stage clinical trials in the EU and US for patients with treatment-resistant depression. We will improve mental health through the development of new patient care pathways, based on advances in neuroscience, psychotherapy, psychopharmacology, and technology.

COMPASS Pathways expert advisers

Professor Sir Alasdair Breckenridge CBE FRSE

  • Former Chairman, UK Medicines & Healthcare products Regulatory Agency
  • Chairman, Centre of Regulatory Excellence Advisory Board

Robin Carhart-Harris PhD

  • Head of Psychedelic Research, Faculty of Medicine at Imperial College London
  • First author on psilocybin clinical trial for treatment-resistant depression, Imperial College (2016)

Mike Emmanuel

  • Former VP Global Clinical Operations for Europe, Middle East & Africa, Janssen Pharmaceuticals
  • Former Associate Director, UK National Institute for Health Research Clinical Research Network

Professor Guy Goodwin FMedSci

  • WA Handley Professor of Psychiatry
  • Former Chair, Department of Psychiatry, University of Oxford
  • Former President, European College of Neuropsychopharmacology

Professor Charles Grob MD

  • Director of the Division of Child and Adolescent Psychiatry at the Harbor-UCLA Medical Center

Tom Insel MD

  • President and Co-Founder, Mindstrong Health
  • Former Lead, Verily Mental Health team
  • Former Director, US National Institute of Mental Health

Marco Mohwinckel

  • Vice President of Strategy, WebMD Health Group
  • Former Global Head, Janssen Solutions and Janssen Healthcare Innovation

David Nichols PhD

  • Professor Emeritus of Pharmacology, Purdue University

Professor Augustus John Rush MD

  • Professor Emeritus of University of Texas Southwestern Medical Center and Duke-NUS Graduate Medical School
  • Recipient of Thomson Reuters: World’s Most Influential Scientific Minds (2014)
  • American Psychiatric Association (APA): Award for Research in Psychiatry (2007)

Paul Summergrad MD

  • Chairman, Psychiatry Department, Tufts University School of Medicine
  • Former President, American Psychiatric Association

About Worldwide Clinical Trials

Worldwide Clinical Trials employs more than 1,600 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world sees CROs – in the best possible way. From early phase and bioanalytical sciences through late phase and post-approval, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune-mediated inflammatory disorders (IMID) and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO. For more information, visit Worldwide.com.

About depression and treatment-resistant depression

  • Depression is one of the fastest growing health problems we face today, and the leading cause of ill-health and disability worldwide. At its worst, it can lead to suicide
  • The WHO estimates that more than 300 million people worldwide are living with depression, an increase of 18% between 2005 and 2015. Of these, about 100 million people suffer with treatment-resistant depression (TRD)
  • Around 25% of people in the EU suffer from anxiety and depression
  • The European Brain Council believes that across the EU, the total annual cost of depression is €118 billion
  • Patients with TRD are likely to have higher medical costs and be associated with lower productivity and quality of life, for themselves and their families

Contact information

COMPASS Pathways:
Tracy Cheung
+44 7966 309024
tracy@compasspathways.com,
or
Chris Strutt
+44 7850 546135
chris@compasspathways.com
or
Worldwide Clinical Trials:
Sherri Stuart, Vice President, Global Marketing and Communications
+1 610-563-8768
Sherri.Stuart@worldwide.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Servier and Taiho Oncology Announce Phase III LONSURF® Study Has Met Primary and Secondary Endpoints Demonstrating Prolonged Overall Survival and Progression-Free Survival in Patients with Refractory Metastatic Gastric Cancer21.10.2018 09:10Pressemelding

Servier and Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), jointly announced today clinical data from the pivotal Phase III TAS-102 Gastric Study (TAGS) evaluating LONSURF® (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pre-treated metastatic gastric cancer who have progressed or are intolerant to previous lines of therapy. The study met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS) consistently supported the OS results, as well as continuing to demonstrate the predictable safety and tolerability profile of trifluridine/tipiracil. Data from TAGS was presented by Dr. Hendrik-Tobias Arkenau, Executive Medical Director of the Sarah Cannon Research Institute UK and an investigator for TAGS, at the ESMO 2018 Congress in Munich, Germany during an oral session (Abstract #LBA25). The study results were simultaneously published in

Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting20.10.2018 22:30Pressemelding

Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced detailed results from the Phase 3 FINCH 2 clinical trial of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents. The data, which are being presented as a late-breaking poster at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, suggest filgotinib has a potential role in addressing important unmet needs in the treatment of rheumatoid arthritis. Positive efficacy data from FINCH 2 were previously announced in September 2018. The data show statistically significant improvements in the proportion of patients achieving a range of clinical efficacy endpoints, including the proportion of patients achieving American College of Rheumatology 20 percent (ACR20, primary endpoint), 50 percent

Manchester United and True Religion Launch Denim Range19.10.2018 17:37Pressemelding

Manchester United (NYSE:MANU) and luxury denim brand True Religion have collaborated to launch a range of premium club branded denim wear. A first for the club, the new global partnership with the iconic American denim brand will see a range of men’s & women’s co-branded styles go on sale beginning 26th October in the club’s Megastore as well as online via United Direct and truereligion.com & eu.truereligion.com. The exclusive collection features jeans, shirts and jackets, including a highly desirable limited edition denim jacket embroidered with the club’s crest. Fans will have the opportunity to win a selection of clothing from the new range by visiting www.manutd.com/truereligion. Manchester United’s Group Managing Director, Richard Arnold, comments: “True Religion is a well-known, established name in fashion, creating unique designs without compromising on quality. The range we have collaborated on includes the same attention to detail and craftsmanship that has made True Religion

Arch Insurance Announces Strategic Leadership Changes19.10.2018 13:10Pressemelding

Arch Insurance today announced that Matt Shulman will assume the newly created role of CEO, Arch Insurance North America, effective January 1, 2019. In this role, he will lead Arch Insurance’s operations in the United States and Canada. He will report to Nicolas Papadopoulo, Chairman and CEO of Arch Worldwide Insurance Group. Mr. Shulman, who has more than 20 years of experience in the insurance industry, has been with Arch Insurance since 2009 and has served as the President and CEO of Arch Insurance Europe since 2016. “Matt brings significant U.S. and international experience to this role. Under his leadership, together with our senior team, Arch Insurance will continue to enhance our value proposition to our customers through a robust, diversified product portfolio, creative solutions and excellent service,” Mr. Papadopoulo said. Arch Insurance has also created a new organizational structure with three Chief Underwriting Officers (CUO) dedicated to specific lines of business. These

Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer19.10.2018 12:00Pressemelding

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1 st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients. Data for these secondary endpoints will be presented in a poster discussion at the European Society for Medical Oncology (ESMO) 2018 Congress on Friday, October 19 at 2:00 p.m. CET in Munich, Germany. These results further support ALUNBRIG as a potential treatment for adults with ALK+ locally advanced or metastatic NSCLC who had not received a prior ALK inhibitor. ALUNBRIG is currently not approved as first-line therapy for advanced ALK+ NSCLC. “ALK+ NSCLC often spreads to the brain, so having options that can clearly demonstrate efficacy both in the brain an

Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Patients With Cystic Fibrosis Aged 12 to <24 months With Certain Mutations in the CFTR Gene19.10.2018 11:54Pressemelding

Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KALYDECO® (ivacaftor) to include the treatment of people with cystic fibrosis (CF) aged 12 to <24 months who have at least one of the following nine mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. If the European Commission issues a favorable adoption of the EMA CHMP opinion for the extension of indication, ivacaftor will be the first and only medicine approved in Europe to treat the underlying cause of CF in patients aged 12 to <24 months, who have specific mutations in the CFTR gene. “Cystic fibrosis is a chronic, progressive disease that is present at birth, with symptoms often occurring in infancy, so early treatment is crucial to deliver the best possible outcomes for patients,” said Reshma Kewalr